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FDA 510(k) Application Details - K200909
Device Classification Name
System, Hemoglobin, Automated
More FDA Info for this Device
510(K) Number
K200909
Device Name
System, Hemoglobin, Automated
Applicant
EKF-diagnostic GmbH
Ebendorfer Chaussee 3
Barleben 39179 DE
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Contact
Andrew J. Rutter
Other 510(k) Applications for this Contact
Regulation Number
864.5620
More FDA Info for this Regulation Number
Classification Product Code
GKR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/06/2020
Decision Date
06/12/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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